FDA 510(k) Application Details - K992732

Device Classification Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days   More FDA Info for this Device
510(K) Number	K992732
Device Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant	DUMEX MEDICAL SURGICAL PRODUCTS, LTD. 104 SHORTING ROAD TORONTO, ONTARIO M1S 3S4 CA Other 510(k) Applications for this Company
Contact	SAM LAKHANI Other 510(k) Applications for this Contact
Regulation Number	880.5200   More FDA Info for this Regulation Number
Classification Product Code	FOZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/13/1999
Decision Date	04/20/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review